Active not recruitingPhase 1

A Study to Investigate the Effect of Elecoglipron on Rosuvastatin and Atorvastatin in Healthy Participants

An Open-label, Fixed-sequence Study to Assess the Effect of Elecoglipron on the Pharmacokinetics of Rosuvastatin and Atorvastatin in Healthy Participants

Lead sponsor

AstraZeneca

Asset

AZD5004 / ECC5004

Oral · GLP-1 agonist

Listed sites

Recruiting sites

Actual enrollment

Study population

Healthy volunteers, Obesity / overweight, Type 2 diabetes

Eligibility highlights

Primary endpoints

•Area under concentration-time curve from time 0 to infinity (AUCinf)•Area under concentration-curve from time 0 to the last quantifiable•Cmax of atorvastatin

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07534592

Org study IDD7260C00028

Timeline

Milestones

Study first posted2026-04-16actual

Study start2026-04-16actual

Last update posted2026-08-28actual

Primary completion2026-10-01estimated

Study completion2026-10-01estimated

Assets

Investigational agents

AZD5004 / ECC5004

Who this study enrolls

Healthy volunteersObesity / overweightType 2 diabetes

Who can enroll

Minimum age18 Years

Maximum age55 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•All females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit.

•Females of childbearing potential must not be lactating and if heterosexually active, must agree to use an approved method of highly effective contraception throughout the study.

•Females of non-childbearing potential must be confirmed as postmenopausal or have documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy but not tubal ligation or tubal occlusion at screening visit.

•Sexually active fertile male participants with partners of childbearing potential must adhere to the contraception methods.

Exclusion criteria

•History of any clinically important disease or disorder.

•Participants with cardiovascular diseases, neuromuscular or neurogenic disease, type 1 or type 2 diabetes mellitus, or positive for human immunodeficiency virus (HIV), or uncontrolled thyroid disease.

•History of acute pancreatitis, history or presence of gastrointestinal (GI) or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.

•Clinically significant inflammatory bowel disease, gastroparesis, severe disease, or surgery affecting the upper GI tract.

•Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of study intervention.

•Any clinically important abnormalities in laboratory values, clinical chemistry, hematology, urinalysis results, or vital signs.

•Any clinically important abnormalities in rhythm, conduction, or morphology of the resting 12-lead electrocardiogram at screening.

•History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity to drugs with a similar chemical structure or class to elecoglipron or paracetamol.

•Participants who have previously received elecoglipron within the last 6 months or was on statin treatment for ≤ 4 weeks prior to the study treatment.

Endpoints (19)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Other (unclassified)

Safety / tolerability / PK

18 endpoints

Primary/protocol endpoint

Area under concentration-time curve from time 0 to infinity (AUCinf) of atorvastatin

Time frame:Group 1: Day 1 to Day 71

concentration, descriptive

Primary/protocol endpoint

Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast) of atorvastatin

Time frame:Group 1: Day 1 to Day 71

concentration, descriptive

Primary/protocol endpoint

Maximum observed drug concentration (Cmax) of atorvastatin

Time frame:Group 1: Day 1 to Day 71

concentration, descriptive

Primary/protocol endpoint

AUCinf of rosuvastatin

Time frame:Group 2: Day 1 to Day 76

descriptive

Primary/protocol endpoint

AUClast of rosuvastatin

Time frame:Group 2: Day 1 to Day 76

descriptive

Primary/protocol endpoint

Cmax of rosuvastatin

Time frame:Group 2: Day 1 to Day 76

concentration, descriptive

Primary/protocol endpoint

Ratio of Atorvastatin (Atorvastatin + elecoglipron) to Atorvastatin (alone) based on AUCinf (R AUCinf) of atorvastatin

Time frame:Group 1: Day 1 to Day 71

ratio, event

Primary/protocol endpoint

Ratio of Atorvastatin (Atorvastatin + elecoglipron) to Atorvastatin (alone) based on AUClast (R AUClast) of atorvastatin

Time frame:Group 1: Day 1 to Day 71

ratio, event

Primary/protocol endpoint

Ratio of Atorvastatin (Atorvastatin + elecoglipron) to Atorvastatin (alone) based on Cmax (R Cmax) of atorvastatin

Time frame:Group 1: Day 1 to Day 71

concentration, descriptive

Primary/protocol endpoint

Terminal elimination half-life (t1/2λz) of atorvastatin

Time frame:Group 1: Day 1 to Day 71

concentration, descriptive

Primary/protocol endpoint

Terminal rate constant (λz) of atorvastatin

Time frame:Group 1: Day 1 to Day 71

descriptive

Primary/protocol endpoint

Time to reach maximum observed concentration (tmax) of atorvastatin

Time frame:Group 1: Day 1 to Day 71

time to event, event

Primary/protocol endpoint

Ratio of Rosuvastatin (Rosuvastatin + elecoglipron) to Rosuvastatin (alone) based on AUCinf (R AUCinf) of rosuvastatin

Time frame:Group 2: Day 1 to Day 76

ratio, event

Primary/protocol endpoint

Ratio of Rosuvastatin (Rosuvastatin + elecoglipron) to Rosuvastatin (alone) based on AUClast (R AUClast) of rosuvastatin

Time frame:Group 2: Day 1 to Day 76

ratio, event

Primary/protocol endpoint

Ratio of Rosuvastatin (Rosuvastatin + elecoglipron) to Rosuvastatin (alone) based on Cmax (R Cmax) of rosuvastatin

Time frame:Group 2: Day 1 to Day 76

concentration, descriptive

Primary/protocol endpoint

t1/2λz of rosuvastatin

Time frame:Group 2: Day 1 to Day 76

concentration, descriptive

Primary/protocol endpoint

tmax of rosuvastatin

Time frame:Group 2: Day 1 to Day 76

concentration, descriptive

Secondary/protocol endpoint

Number of participants with adverse events (AEs) and adverse event of special interest (AESI)

Time frame:Group 1: Day -28 to Day 74; Group 2: Day -28 to Day 79

event count, event

Other (unclassified)

1 endpoint

Primary/protocol endpoint/low confidence

λz of rosuvastatin

Time frame:Group 2: Day 1 to Day 76

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateNovember 5, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the November 5, 2026 snapshot.